A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer

September 26, 2025 updated by: Inova Health Care Services

A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma

This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, or metastatic HCC otherwise not deemed candidates for intensive systemic therapy. In addition to the primary endpoint and multiple secondary efficacy endpoints, we will describe changes in quality of life on treatment over time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
          • Elahe Mollapour
        • Contact:
          • Keary Jane't
        • Principal Investigator:
          • Arthur Winer, MD
      • Falls Church, Virginia, United States, 22042
        • Not yet recruiting
        • Inova Health Care Service
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arthur Winer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 or older.
  2. Patients have newly diagnosed and previously untreated, histologically or radiologically confirmed hepatocellular carcinoma with at least one lesion that is measurable by RECIST 1.1 criteria. A prior HCC lesion that was treated surgically or by radiation is allowed as long as it was at least 2 years or more from the current HCC diagnosis.
  3. Patient's cancer must be deemed locally advanced and unresectable as per the consensus of the Inova Multidisciplinary Cancer Care Conference.
  4. Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a candidate for aggressive systemic treatment.
  5. Eastern Cooperative Oncology Group Performance Status of 0-2.
  6. Patients must have adequate blood counts and organ function.
  7. Memantine is harmful to the human fetus. For this reason, sexually active males with partners of childbearing potential must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study. Women of child bearing potential must have a negative serum pregnancy test result within 24 hours prior to initiation of study treatment. They must also agree to use agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study.
  8. Patients must demonstrate ability to understand and the willingness to sign a written informed consent document.
  9. Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.

Exclusion Criteria:

  1. Patients with Child-Pugh A cirrhosis.
  2. Female patients who are pregnant or breast-feeding.
  3. Concomitant illness or history that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
  4. Life-threatening intercurrent illness.
  5. Anticipated poor compliance.
  6. Subject is enrolled in a separate interventional clinical trial.
  7. Active tuberculosis.
  8. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
  9. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  10. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry for at least 10 days prior to study entry.
  11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment.
  12. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
  13. Patients undergoing other anti-cancer treatment. Palliative radiation for symptom control will be allowed while on protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Namenda
Memantine 5 mg by mouth once daily, to be titrated up to 20 mg daily
Other Names:
  • Memantine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Progression Free Survival at 6 months
Time Frame: 6 months from the start of treatment
The response and progression will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. The progression of the disease is defined as at least a 20% increase in the sum of the Longest Diameter LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions or death due to disease without objective evidence of progression.
6 months from the start of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire for cancer (EORTC QLQ-C30)
Time Frame: 2 years from the initial visit
The EORTC QLQ-C30 consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each score is transformed onto a 0 to 100 point scale. For the symptom scales and single items, a higher score implies a high level of symptoms or problems. Previously published minimally important differences will be used to identify meaningful changes from baseline in each treatment group on the disease and treatment-related symptom scales.
2 years from the initial visit
Change from baseline as assessed by the European Organization for Research and Treatment of Cancer (EORTC-HCC18) over treatment
Time Frame: 2 years from the initial visit
The EORTC QLQ-HCC18 is a disease-specific measure which contains five multi-item symptom scales (fatigue, body image, jaundice, nutrition, and fever), and four single-item measures (shoulder pain, abdominal pain, abdominal swelling, and sex life) for a total of 18 questions with a recall period of the previous week. The EORTC QLQ-HCC18 module takes approximately 5 minutes to complete. All item responses are scored according to the EORTC guidelines for scoring.
2 years from the initial visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Arthur Winer, MD, Inova Health Care Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U23-01-4957

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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